GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5397420Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741012341), received between Jun 27, 2019 and Dec 9, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN EXPIRED DIALYSIS CATHETER WAS ALLEGEDLY IMPLANTED IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440703 ↗
• MalfunctionJun 27, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT A DIALYSIS CATHETER TUNNELER ALLEGEDLY BROKE DURING THE PROCEDURE AFTER COMPLETING THE TUNNEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741080 ↗
• MalfunctionJun 27, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT A DIALYSIS CATHETER TUNNELER ALLEGEDLY BROKE WHILE PLACING THE CATHETER. IT WAS FURTHER REPORTED THAT A PLASTIC PIECE OF THE TUNNELER REMAINED WITHIN THE CATHETER LUMEN AND WAS REMOVED WITH CLAMPS. THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT COMPLICATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8740368 ↗